Application 202992

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUBAGIO	TERIFLUNOMIDE	TABLET;ORAL	7MG	Yes	No
002	AUBAGIO	TERIFLUNOMIDE	TABLET;ORAL	14MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corp.	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0210	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corp.	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current
58468-0211	Aubagio	teriflunomide	Genzyme Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85059	SUPPL	2026-02-18
85033	SUPPL	2026-02-12
85064	SUPPL	2026-02-11
78770	SUPPL	2024-06-12
78764	SUPPL	2024-06-11
67411	SUPPL	2021-05-05
67410	SUPPL	2021-05-05
67407	SUPPL	2021-05-05
67393	SUPPL	2021-05-04
67392	SUPPL	2021-05-04
65198	SUPPL	2020-11-12
65178	SUPPL	2020-11-10
65177	SUPPL	2020-11-10
65168	SUPPL	2020-11-09
65167	SUPPL	2020-11-09
62017	SUPPL	2020-03-04
62014	SUPPL	2020-03-03
59944	SUPPL	2019-09-09
59943	SUPPL	2019-09-09
59941	SUPPL	2019-09-09
59448	SUPPL	2019-07-25
59447	SUPPL	2019-07-25
59444	SUPPL	2019-07-25
50904	SUPPL	2017-12-27
45994	SUPPL	2016-12-01
45978	SUPPL	2016-12-01
40247	SUPPL	2016-06-06
10143	SUPPL	2016-06-06
32347	SUPPL	2014-10-22
19406	SUPPL	2014-10-21
44873	ORIG	2012-11-05
22905	ORIG	2012-11-05
19405	ORIG	2012-09-14
10142	ORIG	2012-09-14

Application 202992

Related Records#

Application Products#

NDC Listings For This Application#

Documents#